Drug Evaluation Committee Statement from the Data Science Subcommittee of the Drug Evaluation Committee on COVID-19
In light of the COVID-19 pandemic that began in 2020, we trust that all companies are taking appropriate measures.
Member companies of the JPMA must also conduct clinical trials appropriately while implementing measures to prevent the spread of infection.
Issues related to statistical analysis may arise once a clinical trial enters its final stages, and there are likely tasks that need to be addressed in advance regarding statistical analysis plans and data management.
Therefore, the Data Science Subcommittee has compiled a summary of potential future issues and how to address them from the perspectives of statistical analysis and data management. We have issued this summary in the form of a statement titled “The Impact of COVID-19 on Clinical Trials: Perspectives on Statistical Analysis and Data Management,” and we ask that you widely share it with all relevant parties.
May 11, 2020
Japan Pharmaceutical Manufacturers Association (JPMA) Drug Evaluation Committee
Data Science Subcommittee